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Implementing Virtual Reality in the Operating Room (IRVABO)

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ClinicalTrials.gov Identifier: NCT06333639
Recruitment Status : Not yet recruiting
First Posted : March 27, 2024
Last Update Posted : March 27, 2024
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Tracking Information
First Submitted Date March 21, 2024
First Posted Date March 27, 2024
Last Update Posted Date March 27, 2024
Estimated Study Start Date April 1, 2024
Estimated Primary Completion Date October 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 21, 2024)		 To demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset. [ Time Frame: Immediate post-operative ]
Patient satisfaction with their surgical experience. This will be measured using a Likert scale, graduated from 0 to 10, with 0 being the minimum and 10 the maximum.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 21, 2024)
  • 1. To demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on the doses of premedication, compared with the same surgeries without headset. [ Time Frame: Immediate post-operative ]
    1. The number and doses of Midazolam (in mg) received in the two distinct groups will make it possible to evaluate the effectiveness of virtual reality from a pharmaceutical point of view. A difference in the use of pharmaceutical therapeutics of 20% less in patients with VR is expected to be significant. If the difference is less, the doses of premedication used in the two groups will be compared in order to assess the positive impact of VR.
  • Evaluate the Virtual Reality device in terms of comfort when wearing the headset, visual comfort and image and scenario quality, and auditory quality [ Time Frame: Immediate post-operative ]
    2. VR evaluated using a Likert scale from 0 to as well as an open-ended questionnaire evaluating (isolation from noise pollution, possibility of communicating with nursing staff, quality of audio transmitted) : The comfort of wearing the helmet Visual comfort, image and scenario quality Hearing quality (isolation from noise pollution, ability to communicate with nursing staff, quality of audio transmitted)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Implementing Virtual Reality in the Operating Room
Official Title Implementing Virtual Reality in the Operating Room : Patient Satisfaction During Long Orthopaedic Surgery Under Locoregional Anaesthesia
Brief Summary

"Recently, virtual reality has become more accessible thanks to the use of smaller, more comfortable and easier-to-use devices. Its use in operating theatres is growing.

However, despite the clinical effectiveness of virtual reality in reducing pain and anxiety, there are very few feedback studies from patients on their experience of surgery and their satisfaction, especially in orthopaedics.

The aim of this study is to demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset.

The visual support offered will be appropriate to the duration of the surgery, i.e. more than 1 hour."
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Major patients admitted for total hip or knee replacement surgery and whose anaesthetic management is by loco-regional anaesthesia
Condition
  • General Surgery
  • Orthopedic Procedures
Intervention
  • Other: orthopaedic surgery
    usual procedures for an orthopaedic surgery
  • Other: orthopaedic surgery and fitted with a virtual reality headset
    usual procedures for an orthopaedic surgery and fitted with a virtual reality headset
Study Groups/Cohorts
  • orthopaedic surgery (goup 1 control)
    30 individuals installed according to the usual procedures for an orthopaedic surgery
    Intervention: Other: orthopaedic surgery
  • orthopaedic surgery and fitted with a virtual reality headset (group 2 case)
    30 individuals installed according to the usual procedures for an orthopaedic surgery and fitted with a virtual reality headset
    Intervention: Other: orthopaedic surgery and fitted with a virtual reality headset
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: March 21, 2024)		 60
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 15, 2024
Estimated Primary Completion Date October 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient 18 years of age or older
  • Patient admitted for total hip or knee replacement surgery.
  • Patient undergoing anaesthetic management by loco-regional anaesthesia
  • Affiliation to a French health insurance scheme or equivalent
  • Patient who has given his non-opposition agreement

Exclusion Criteria:

  • Patient with a neurological disorder (coma, dementia, confusion, photosensitive epilepsy)
  • Patient with a severe psychiatric disorder
  • Patients with severe deafness or visual impairment
  • Language barrier
  • Pregnant or breast-feeding women of childbearing age
  • Refusal of patient involvement
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: GAUCI Marc-Olivier 04 92 03 69 04 ext +33 gauci.mo@chu-nice.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT06333639
Other Study ID Numbers 24Chirortho01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Centre Hospitalier Universitaire de Nice
Original Responsible Party Same as current
Current Study Sponsor Centre Hospitalier Universitaire de Nice
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date March 2024